Updates in DMTs and MS Economic Burden From ACTRIMS 2022

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Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

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Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

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Excess weight over lifetime hikes risk for colorectal cancer

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Excess weight over a lifetime may play a greater role in a person’s risk for colorectal cancer (CRC) than previously thought, according to new research.

In their paper published online March 17 in JAMA Oncology, the authors liken the cumulative effects of a lifetime with overweight or obesity to the increased risk of cancer the more people smoke over time.

This population-based, case-control study was led by Xiangwei Li, MSc, of the division of clinical epidemiology and aging research at the German Cancer Research Center in Heidelberg.

It looked at height and self-reported weight documented in 10-year increments starting at age 20 years up to the current age for 5,635 people with CRC compared with 4,515 people in a control group.

Odds for colorectal cancer increased substantially over the decades when people carried the excess weight long term compared with participants who remained within the normal weight range during the period.

Dr. Hermann Brenner

Coauthor Hermann Brenner, MD, MPH, a colleague in Li’s division at the German Cancer Research Center, said in an interview that a key message in the research is that “overweight and obesity are likely to increase the risk of colorectal cancer more strongly than suggested by previous studies that typically had considered body weight only at a single point of time.”

The researchers used a measure of weighted number of years lived with overweight or obesity (WYOs) determined by multiplying excess body mass index by number of years the person carried the excess weight.

They found a link between WYOs and CRC risk, with adjusted odds ratios (ORs) increasing from 1.25 (95% confidence interval [CI], 1.09-1.44) to 2.54 (95% CI, 2.24-2.89) from the first to the fourth quartile of WYOs, compared with people who stayed within normal weight parameters.

The odds went up substantially the longer the time carrying the excess weight.

“Each SD increment in WYOs was associated with an increase of CRC risk by 55% (adjusted OR, 1.55; 95% CI, 1.46-1.64),” the authors wrote. “This OR was higher than the OR per SD increase of excess body mass index at any single point of time, which ranged from 1.04 (95% CI, 0.93-1.16) to 1.27 (95% CI 1.16-1.39).”

Dr. Brenner said that although this study focused on colorectal cancer, “the same is likely to apply for other cancers and other chronic diseases.”

Prevention of overweight and obesity to reduce burden of cancer and other chronic diseases “should become a public health priority,” he said.
 

Preventing overweight in childhood is important

Overweight and obesity increasingly are starting in childhood, he noted, and may be a lifelong burden.

Therefore, “efforts to prevent their development in childhood, adolescence, and young adulthood are particularly important,” Dr. Brenner said.

The average age of the patients was 68 years in both the CRC and control groups. There were more men than women in both groups: 59.7% were men in the CRC group and 61.1% were men in the control group.

“Our proposed concept of WYOs is comparable to the concept of pack-years in that WYOs can be considered a weighted measure of years lived with the exposure, with weights reflecting the intensity of exposure,” the authors wrote.
 

 

 

Study helps confirm what is becoming more clear to researchers

Kimmie Ng, MD, MPH, a professor at Harvard Medical School and oncologist at Dana-Farber Cancer Institute, both in Boston, said in an interview that the study helps confirm what is becoming more clear to researchers.

Dr. Kimmie Ng

“We do think that exposures over the life course are the ones that will be most strongly contributing to a risk of colorectal cancer as an adult,” she said. “With obesity, what we think is happening is that it’s setting up this milieu of chronic inflammation and insulin resistance and we know those two factors can lead to higher rates of colorectal cancer development and increased tumor growth.”

She said the ideal, but impractical, way to do the study would be to follow healthy people from childhood and document their weight over a lifetime. In this case-control study, people were asked to recall their weight at different time periods, which is a limitation and could lead to recall bias.

But the study is important, Dr. Ng said, and it adds convincing evidence that addressing the link between excess weight and CRC and chronic diseases should be a public health priority. “With the recent rise in young-onset colorectal cancer since the 1990s there has been a lot of interest in looking at whether obesity is a major contributor to that rising trend,” Dr. Ng noted. “If obesity is truly linked to colorectal cancer, these rising rates of obesity are very worrisome for potentially leading to more colorectal cancers in young adulthood and beyond.“

The study authors and Dr. Ng report no relevant financial relationships.

The new research was funded by the German Research Council, the Interdisciplinary Research Program of the National Center for Tumor Diseases, Germany, and the German Federal Ministry of Education and Research.

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Excess weight over a lifetime may play a greater role in a person’s risk for colorectal cancer (CRC) than previously thought, according to new research.

In their paper published online March 17 in JAMA Oncology, the authors liken the cumulative effects of a lifetime with overweight or obesity to the increased risk of cancer the more people smoke over time.

This population-based, case-control study was led by Xiangwei Li, MSc, of the division of clinical epidemiology and aging research at the German Cancer Research Center in Heidelberg.

It looked at height and self-reported weight documented in 10-year increments starting at age 20 years up to the current age for 5,635 people with CRC compared with 4,515 people in a control group.

Odds for colorectal cancer increased substantially over the decades when people carried the excess weight long term compared with participants who remained within the normal weight range during the period.

Dr. Hermann Brenner

Coauthor Hermann Brenner, MD, MPH, a colleague in Li’s division at the German Cancer Research Center, said in an interview that a key message in the research is that “overweight and obesity are likely to increase the risk of colorectal cancer more strongly than suggested by previous studies that typically had considered body weight only at a single point of time.”

The researchers used a measure of weighted number of years lived with overweight or obesity (WYOs) determined by multiplying excess body mass index by number of years the person carried the excess weight.

They found a link between WYOs and CRC risk, with adjusted odds ratios (ORs) increasing from 1.25 (95% confidence interval [CI], 1.09-1.44) to 2.54 (95% CI, 2.24-2.89) from the first to the fourth quartile of WYOs, compared with people who stayed within normal weight parameters.

The odds went up substantially the longer the time carrying the excess weight.

“Each SD increment in WYOs was associated with an increase of CRC risk by 55% (adjusted OR, 1.55; 95% CI, 1.46-1.64),” the authors wrote. “This OR was higher than the OR per SD increase of excess body mass index at any single point of time, which ranged from 1.04 (95% CI, 0.93-1.16) to 1.27 (95% CI 1.16-1.39).”

Dr. Brenner said that although this study focused on colorectal cancer, “the same is likely to apply for other cancers and other chronic diseases.”

Prevention of overweight and obesity to reduce burden of cancer and other chronic diseases “should become a public health priority,” he said.
 

Preventing overweight in childhood is important

Overweight and obesity increasingly are starting in childhood, he noted, and may be a lifelong burden.

Therefore, “efforts to prevent their development in childhood, adolescence, and young adulthood are particularly important,” Dr. Brenner said.

The average age of the patients was 68 years in both the CRC and control groups. There were more men than women in both groups: 59.7% were men in the CRC group and 61.1% were men in the control group.

“Our proposed concept of WYOs is comparable to the concept of pack-years in that WYOs can be considered a weighted measure of years lived with the exposure, with weights reflecting the intensity of exposure,” the authors wrote.
 

 

 

Study helps confirm what is becoming more clear to researchers

Kimmie Ng, MD, MPH, a professor at Harvard Medical School and oncologist at Dana-Farber Cancer Institute, both in Boston, said in an interview that the study helps confirm what is becoming more clear to researchers.

Dr. Kimmie Ng

“We do think that exposures over the life course are the ones that will be most strongly contributing to a risk of colorectal cancer as an adult,” she said. “With obesity, what we think is happening is that it’s setting up this milieu of chronic inflammation and insulin resistance and we know those two factors can lead to higher rates of colorectal cancer development and increased tumor growth.”

She said the ideal, but impractical, way to do the study would be to follow healthy people from childhood and document their weight over a lifetime. In this case-control study, people were asked to recall their weight at different time periods, which is a limitation and could lead to recall bias.

But the study is important, Dr. Ng said, and it adds convincing evidence that addressing the link between excess weight and CRC and chronic diseases should be a public health priority. “With the recent rise in young-onset colorectal cancer since the 1990s there has been a lot of interest in looking at whether obesity is a major contributor to that rising trend,” Dr. Ng noted. “If obesity is truly linked to colorectal cancer, these rising rates of obesity are very worrisome for potentially leading to more colorectal cancers in young adulthood and beyond.“

The study authors and Dr. Ng report no relevant financial relationships.

The new research was funded by the German Research Council, the Interdisciplinary Research Program of the National Center for Tumor Diseases, Germany, and the German Federal Ministry of Education and Research.

Excess weight over a lifetime may play a greater role in a person’s risk for colorectal cancer (CRC) than previously thought, according to new research.

In their paper published online March 17 in JAMA Oncology, the authors liken the cumulative effects of a lifetime with overweight or obesity to the increased risk of cancer the more people smoke over time.

This population-based, case-control study was led by Xiangwei Li, MSc, of the division of clinical epidemiology and aging research at the German Cancer Research Center in Heidelberg.

It looked at height and self-reported weight documented in 10-year increments starting at age 20 years up to the current age for 5,635 people with CRC compared with 4,515 people in a control group.

Odds for colorectal cancer increased substantially over the decades when people carried the excess weight long term compared with participants who remained within the normal weight range during the period.

Dr. Hermann Brenner

Coauthor Hermann Brenner, MD, MPH, a colleague in Li’s division at the German Cancer Research Center, said in an interview that a key message in the research is that “overweight and obesity are likely to increase the risk of colorectal cancer more strongly than suggested by previous studies that typically had considered body weight only at a single point of time.”

The researchers used a measure of weighted number of years lived with overweight or obesity (WYOs) determined by multiplying excess body mass index by number of years the person carried the excess weight.

They found a link between WYOs and CRC risk, with adjusted odds ratios (ORs) increasing from 1.25 (95% confidence interval [CI], 1.09-1.44) to 2.54 (95% CI, 2.24-2.89) from the first to the fourth quartile of WYOs, compared with people who stayed within normal weight parameters.

The odds went up substantially the longer the time carrying the excess weight.

“Each SD increment in WYOs was associated with an increase of CRC risk by 55% (adjusted OR, 1.55; 95% CI, 1.46-1.64),” the authors wrote. “This OR was higher than the OR per SD increase of excess body mass index at any single point of time, which ranged from 1.04 (95% CI, 0.93-1.16) to 1.27 (95% CI 1.16-1.39).”

Dr. Brenner said that although this study focused on colorectal cancer, “the same is likely to apply for other cancers and other chronic diseases.”

Prevention of overweight and obesity to reduce burden of cancer and other chronic diseases “should become a public health priority,” he said.
 

Preventing overweight in childhood is important

Overweight and obesity increasingly are starting in childhood, he noted, and may be a lifelong burden.

Therefore, “efforts to prevent their development in childhood, adolescence, and young adulthood are particularly important,” Dr. Brenner said.

The average age of the patients was 68 years in both the CRC and control groups. There were more men than women in both groups: 59.7% were men in the CRC group and 61.1% were men in the control group.

“Our proposed concept of WYOs is comparable to the concept of pack-years in that WYOs can be considered a weighted measure of years lived with the exposure, with weights reflecting the intensity of exposure,” the authors wrote.
 

 

 

Study helps confirm what is becoming more clear to researchers

Kimmie Ng, MD, MPH, a professor at Harvard Medical School and oncologist at Dana-Farber Cancer Institute, both in Boston, said in an interview that the study helps confirm what is becoming more clear to researchers.

Dr. Kimmie Ng

“We do think that exposures over the life course are the ones that will be most strongly contributing to a risk of colorectal cancer as an adult,” she said. “With obesity, what we think is happening is that it’s setting up this milieu of chronic inflammation and insulin resistance and we know those two factors can lead to higher rates of colorectal cancer development and increased tumor growth.”

She said the ideal, but impractical, way to do the study would be to follow healthy people from childhood and document their weight over a lifetime. In this case-control study, people were asked to recall their weight at different time periods, which is a limitation and could lead to recall bias.

But the study is important, Dr. Ng said, and it adds convincing evidence that addressing the link between excess weight and CRC and chronic diseases should be a public health priority. “With the recent rise in young-onset colorectal cancer since the 1990s there has been a lot of interest in looking at whether obesity is a major contributor to that rising trend,” Dr. Ng noted. “If obesity is truly linked to colorectal cancer, these rising rates of obesity are very worrisome for potentially leading to more colorectal cancers in young adulthood and beyond.“

The study authors and Dr. Ng report no relevant financial relationships.

The new research was funded by the German Research Council, the Interdisciplinary Research Program of the National Center for Tumor Diseases, Germany, and the German Federal Ministry of Education and Research.

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Sleep experts recommend permanent standard time, rather than DST

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Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

A version of this article first appeared on WebMD.com.

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Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

A version of this article first appeared on WebMD.com.

Sleep experts tend to agree with U.S. lawmakers about getting rid of the twice-per-year time shift, with one exception: They typically call for standard time rather than daylight saving time.

After the Senate voted unanimously on March 15 to make daylight saving time permanent, the American Academy of Sleep Medicine issued a statement that urged caution about adopting a fixed, year-round time with potential health risks.

“We do applaud stopping the switching during the course of the year and settling on a permanent time,” Jocelyn Cheng, MD, a member of the association’s public safety committee, told The Washington Post.

But “standard time, for so many scientific and circadian rationales and public health safety reasons, should really be what the permanent time is set to,” she said.

Now it’s up to the House of Representatives to decide what to do next. The legislation, which would take effect in 2023, must be passed by the House and signed by President Joe Biden before becoming a law.

Legislators and health experts have debated the shift in recent years. In 2020, the American Academy of Sleep Medicine released a position statement in the Journal of Clinical Sleep Medicine that recommended that the United States move to year-round standard time. Standard time is more aligned with humans’ circadian rhythms and natural light/dark cycles, the group wrote, and disrupting that rhythm has been linked to higher risks of heart disease, obesity, and depression.

At the same time, few studies have focused on the long-term effects of adopting daylight saving time. Most research has focused on the short-term risks of the seasonal shift, such as reduced sleep and increased car crashes, or circadian misalignment caused by other things. Some health experts have called for more research before deciding on a permanent time, the newspaper reported.

Still, the March 15 statement from sleep experts received support from more than 20 groups, including the National Safety Council, National Parent Teacher Association, and the World Sleep Society.

“We have all enjoyed those summer evenings with seemingly endless dusks,” David Neubauer, MD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, told the Post.

But daylight saving time “does not ‘save’ evening light at all, it simply steals it from the morning, when it is necessary to maintain our healthy biological rhythms,” he said.

Permanent daylight saving time would lead to more dark mornings, which opponents have said could be dangerous for kids going to school, adults driving to work, and overall sleep cycles.

“With daylight saving time, we are perpetually out of synchronization with our internal clocks, and we often achieve less nighttime sleep, both circumstances having negative health impacts,” Dr. Neubauer said. “Extra evening light suppresses the melatonin that should be preparing us for falling asleep. The later dawn during daylight saving time deprives our biological clocks of the critical light signal.”

The pros and cons of daylight saving time and standard time were debated during a hearing held by a House Energy and Commerce subcommittee recently. Sleep experts argued in favor of standard time, while other industry experts argued for daylight saving time to reduce crime, save energy, and help businesses that benefit from more daylight in the evenings.

“Everybody advocates a permanent time, but this difference between 1 hour back or 1 hour forward is not so clear in everybody’s mind,” Dr. Cheng said. “I would like to see further debate and some due diligence done on these health consequences and public safety measures before anything else goes forward.”

A version of this article first appeared on WebMD.com.

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COVID surge in Western Europe puts U.S. health experts on alert

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A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

A version of this article first appeared on WebMD.com.

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A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

A version of this article first appeared on WebMD.com.

A new surge in COVID-19 cases across Western Europe has led U.S. health officials to consider whether another pandemic wave will arrive soon, even as states and cities continue to lift restrictions amid low case numbers.

Infectious disease experts are watching BA.2, the Omicron subvariant that appears to be more transmissible than the original strain. BA.2 is fueling outbreaks across Europe and is growing in dominance across the United States.

“It’s picking up steam. It’s across at least 12 countries … from Finland to Greece,” Eric Topol, MD, director of the Scripps Research Translational Institute, told The Washington Post.

He has been following the surge and has posted recent charts of the outbreak on Twitter. Hospitalizations appear to be increasing in some places as well, he noted, despite the higher vaccination rates of many Western European countries.

“There’s no question there’s a significant wave there,” Dr. Topol said.

Germany recorded more than 260,000 new cases on March 15, according to the data tracker from the New York Times, but coronavirus restrictions are still being lifted this week. The U.K. is reporting more than 75,000 daily cases, and the Netherlands is reporting more than 60,000 daily cases, which are considered major numbers, compared to their population sizes. Meanwhile, France, Italy, and Switzerland are also reporting large increases in infections.

During the past 2 years, widespread outbreaks in Europe have been followed by similar surges in the U.S. weeks later. Most experts interviewed by the Post predicted that it’s likely to happen again.

In the United States, the BA.2 subvariant accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the Centers for Disease Control and Prevention, while the original Omicron strain made up about 66% of cases. The BA.2 percentage is up from 13.7% of new cases for the week ending March 5, 7.1% the previous week, and 4.1% the week before that. In parts of the Northeast and New England, BA.2 makes up more than 38% of new cases.

At the same time, the 7 -day average of COVID-19 cases continues to drop in the United States, with about 31,000 daily cases currently, the New York Times data tracker shows. About 25,000 COVID-19 patients are hospitalized across the country, which has fallen 44% in the past 2 weeks, and about 1,200 deaths are being reported daily.

Several variables could affect the course of a future surge, the Post reported. Vaccination rates, coronavirus safety protocols, and access to antiviral medications could dictate how another wave unfolds across the country.

About 82% of the eligible U.S. population has received at least one vaccine dose, and 69% is fully vaccinated, according to the latest CDC data. About half of those who are eligible for booster doses have received one. In Germany, nearly 76% of people are fully vaccinated, the newspaper reported, and in the United Kingdom, about 74% are fully vaccinated.

Health experts are also considering how natural immunity from a previous infection could affect a BA.2 surge. Millions of Americans were infected with the original Omicron strain, BA.1, which could provide protection. That said, researchers aren’t quite sure whether BA.1 infection protects against BA.2.

“It’s like a weather alert. Right now, the skies are sunny and bright, and we hope they stay that way,” Michael Osterholm, PhD, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told CNN.

“But we could have some bad weather by evening,” he said. “We just don’t know.”

A version of this article first appeared on WebMD.com.

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Waiting for the under-5 COVID-19 vaccine

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Fri, 03/18/2022 - 16:36

In February, citing the need for more data, Pfizer and BioNTech announced that they were delaying the application for their COVID-19 vaccine for children under the age of 5. Earlier evidence suggests that two doses may not provide adequate protection in the 2- to 4-year old age group. With the larger number of infections and illness in the younger age group from the Omicron variant, Pfizer and BioNTech felt they needed more data on the effectiveness of a third dose.

This delay came as a disappointment to parents of children under 5 who have been eager to have them receive the vaccination. However, Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, told parents that this delay should be reassuring – that the companies were doing important due diligence before releasing a product that is both safe and effective. The American Academy of Pediatrics wisely released a similar statement of reassurance and support.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

It is difficult to know how many parents will eventually immunize their young children once the vaccine is approved. Any survey done more than a few weeks ago must be viewed cautiously as “the COVID numbers” around the country continue to improve and parental attitudes are likely to change.

There will always remain subgroups of parents on either extreme of the bell-shaped curve. Some will reject the under-5 vaccine simply because it is a vaccine. Some parents are so anxious to vaccinate that they will want to be first in line even if waiting is the more prudent approach. In a recent opinion piece appearing in the New York Times, a statistician writes that he is so eager to have his young children immunized that he is encouraging the FDA to replace its traditional reliance on “statistical significance” with a less rigid and binary method such as one based on Bayesian theory (Aubrey Carlton, “I’m a parent and a statistician. There’s a smarter way to think about the under-5 vaccine.” The New York Times. 2022 Mar 1.). However, what this statistician misses in his haste to vaccinate his own children is that we are dealing with an entire population with varying levels of scientific sophistication and appetite for risk. While “statistical significance” may no longer be cutting edge to some statisticians, most of the rest of the country finds the term reassuring.

It will be interesting to see what happens if and when the vaccine is approved. Will the American Academy of Pediatrics come out with a strong recommendation? I hope they are careful and provide a sufficient number of caveats, otherwise we in the trenches will again be left to provide more nuanced advice to families who are both anxious and hesitant.

Despite the recent surge in cases among young children, apparently as a result of the Omicron variant, the disease continues to cause less and milder disease among young children than it does in adults. And the degree to which illness in the pediatric population contributes to the health of the general population appears to still be a matter of debate. This may be yet another instance of when the crafty COVID-19 has moved with a pace that will make an under–age-5 vaccine of relatively little value.

First, we must be careful to assure ourselves that any side effects the vaccine might generate are well within an even more restricted acceptable range. Second, we must be careful not to squander our persuasive currency by promoting a vaccine that in retrospect may turn out to be of relatively little value.

Although there is ample evidence that education often fails to convince the committed anti-vaxxers, pediatricians continue to be held in high regard by most parents, many of whom are understandably confused by the tsunami of health information of mixed quality generated by the pandemic. We must be cautious not to cast ourselves as a group whose knee-jerk reaction is to recommend every vaccine with equal vigor. All vaccines are not created equal. We must be patient and prepared to adjust the level of our enthusiasm. We must continue to tailor our advice based on the hard data. Otherwise, parents will stop asking for our advice because they will believe that they already know what we’re going to say.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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In February, citing the need for more data, Pfizer and BioNTech announced that they were delaying the application for their COVID-19 vaccine for children under the age of 5. Earlier evidence suggests that two doses may not provide adequate protection in the 2- to 4-year old age group. With the larger number of infections and illness in the younger age group from the Omicron variant, Pfizer and BioNTech felt they needed more data on the effectiveness of a third dose.

This delay came as a disappointment to parents of children under 5 who have been eager to have them receive the vaccination. However, Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, told parents that this delay should be reassuring – that the companies were doing important due diligence before releasing a product that is both safe and effective. The American Academy of Pediatrics wisely released a similar statement of reassurance and support.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

It is difficult to know how many parents will eventually immunize their young children once the vaccine is approved. Any survey done more than a few weeks ago must be viewed cautiously as “the COVID numbers” around the country continue to improve and parental attitudes are likely to change.

There will always remain subgroups of parents on either extreme of the bell-shaped curve. Some will reject the under-5 vaccine simply because it is a vaccine. Some parents are so anxious to vaccinate that they will want to be first in line even if waiting is the more prudent approach. In a recent opinion piece appearing in the New York Times, a statistician writes that he is so eager to have his young children immunized that he is encouraging the FDA to replace its traditional reliance on “statistical significance” with a less rigid and binary method such as one based on Bayesian theory (Aubrey Carlton, “I’m a parent and a statistician. There’s a smarter way to think about the under-5 vaccine.” The New York Times. 2022 Mar 1.). However, what this statistician misses in his haste to vaccinate his own children is that we are dealing with an entire population with varying levels of scientific sophistication and appetite for risk. While “statistical significance” may no longer be cutting edge to some statisticians, most of the rest of the country finds the term reassuring.

It will be interesting to see what happens if and when the vaccine is approved. Will the American Academy of Pediatrics come out with a strong recommendation? I hope they are careful and provide a sufficient number of caveats, otherwise we in the trenches will again be left to provide more nuanced advice to families who are both anxious and hesitant.

Despite the recent surge in cases among young children, apparently as a result of the Omicron variant, the disease continues to cause less and milder disease among young children than it does in adults. And the degree to which illness in the pediatric population contributes to the health of the general population appears to still be a matter of debate. This may be yet another instance of when the crafty COVID-19 has moved with a pace that will make an under–age-5 vaccine of relatively little value.

First, we must be careful to assure ourselves that any side effects the vaccine might generate are well within an even more restricted acceptable range. Second, we must be careful not to squander our persuasive currency by promoting a vaccine that in retrospect may turn out to be of relatively little value.

Although there is ample evidence that education often fails to convince the committed anti-vaxxers, pediatricians continue to be held in high regard by most parents, many of whom are understandably confused by the tsunami of health information of mixed quality generated by the pandemic. We must be cautious not to cast ourselves as a group whose knee-jerk reaction is to recommend every vaccine with equal vigor. All vaccines are not created equal. We must be patient and prepared to adjust the level of our enthusiasm. We must continue to tailor our advice based on the hard data. Otherwise, parents will stop asking for our advice because they will believe that they already know what we’re going to say.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In February, citing the need for more data, Pfizer and BioNTech announced that they were delaying the application for their COVID-19 vaccine for children under the age of 5. Earlier evidence suggests that two doses may not provide adequate protection in the 2- to 4-year old age group. With the larger number of infections and illness in the younger age group from the Omicron variant, Pfizer and BioNTech felt they needed more data on the effectiveness of a third dose.

This delay came as a disappointment to parents of children under 5 who have been eager to have them receive the vaccination. However, Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, told parents that this delay should be reassuring – that the companies were doing important due diligence before releasing a product that is both safe and effective. The American Academy of Pediatrics wisely released a similar statement of reassurance and support.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

It is difficult to know how many parents will eventually immunize their young children once the vaccine is approved. Any survey done more than a few weeks ago must be viewed cautiously as “the COVID numbers” around the country continue to improve and parental attitudes are likely to change.

There will always remain subgroups of parents on either extreme of the bell-shaped curve. Some will reject the under-5 vaccine simply because it is a vaccine. Some parents are so anxious to vaccinate that they will want to be first in line even if waiting is the more prudent approach. In a recent opinion piece appearing in the New York Times, a statistician writes that he is so eager to have his young children immunized that he is encouraging the FDA to replace its traditional reliance on “statistical significance” with a less rigid and binary method such as one based on Bayesian theory (Aubrey Carlton, “I’m a parent and a statistician. There’s a smarter way to think about the under-5 vaccine.” The New York Times. 2022 Mar 1.). However, what this statistician misses in his haste to vaccinate his own children is that we are dealing with an entire population with varying levels of scientific sophistication and appetite for risk. While “statistical significance” may no longer be cutting edge to some statisticians, most of the rest of the country finds the term reassuring.

It will be interesting to see what happens if and when the vaccine is approved. Will the American Academy of Pediatrics come out with a strong recommendation? I hope they are careful and provide a sufficient number of caveats, otherwise we in the trenches will again be left to provide more nuanced advice to families who are both anxious and hesitant.

Despite the recent surge in cases among young children, apparently as a result of the Omicron variant, the disease continues to cause less and milder disease among young children than it does in adults. And the degree to which illness in the pediatric population contributes to the health of the general population appears to still be a matter of debate. This may be yet another instance of when the crafty COVID-19 has moved with a pace that will make an under–age-5 vaccine of relatively little value.

First, we must be careful to assure ourselves that any side effects the vaccine might generate are well within an even more restricted acceptable range. Second, we must be careful not to squander our persuasive currency by promoting a vaccine that in retrospect may turn out to be of relatively little value.

Although there is ample evidence that education often fails to convince the committed anti-vaxxers, pediatricians continue to be held in high regard by most parents, many of whom are understandably confused by the tsunami of health information of mixed quality generated by the pandemic. We must be cautious not to cast ourselves as a group whose knee-jerk reaction is to recommend every vaccine with equal vigor. All vaccines are not created equal. We must be patient and prepared to adjust the level of our enthusiasm. We must continue to tailor our advice based on the hard data. Otherwise, parents will stop asking for our advice because they will believe that they already know what we’re going to say.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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Answering parents’ questions about Cronobacter and powdered formula

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Fri, 03/18/2022 - 10:43
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Answering parents’ questions about Cronobacter and powdered formula

A 6-month-old boy presented with 2 days of looser-than-normal stools without blood or mucous. Before the onset of diarrhea, he had been fed at least two bottles of an infant formula identified in a national recall. His mom requested testing for Cronobacter sakazakii.

In mid-February, Abbott Nutrition recalled specific lots of powdered formula produced at one Michigan manufacturing facility because of possible Cronobacter contamination. To date, a public health investigation has identified four infants in three states who developed Cronobacter infection after consuming formula that was part of the recall. Two of the infants died.

Dr. Kristina A. Bryant

As media reports urged families to search their kitchens for containers of the implicated formula and return them for a refund, worried parents reached out to pediatric care providers for advice.

Cronobacter sakazakii and other Cronobacter species are Gram-negative environmental organisms that occasionally cause bacteremia and meningitis in young infants. Although these infections are not subject to mandatory reporting in most states, laboratory-based surveillance suggests that 18 cases occur annually in the United States (0.49 cases/100,00 infants).

While early reports in the literature described cases in hospitalized, preterm infants, infections also occur in the community and in children born at or near term. A Centers for Disease Control and Prevention review of domestic and international cases identified 183 children <12 months of age between 1961 and 2018 described as diagnosed with Cronobacter bacteremia or meningitis.1 Of the 79 U.S. cases, 34 occurred in term infants and 50 were community onset. Most cases occurred in the first month of life; the oldest child was 35 days of age at the onset of symptoms. Meningitis was more likely in infants born close to term and who were not hospitalized at the time of infection. The majority of infants for whom a feeding history was available had consumed powdered formula.

Back in the exam room, the 6-month-old was examined and found to be vigorous and well-appearing with normal vital signs and no signs of dehydration. The infant’s pediatrician found no clinical indication to perform a blood culture or lumbar puncture, the tests used to diagnose invasive Cronobacter infection. She explained that stool cultures are not recommended, as Cronobacter does not usually cause diarrhea in infants and finding the bacteria in the stool may represent colonization rather than infection.

The pediatrician did take the opportunity to talk to the mom about her formula preparation practices and shared a handout. Powdered formula isn’t sterile, but it is safe for most infants when prepared according to manufacturer’s directions. Contamination of formula during or after preparation can also result in Cronobacter infection in vulnerable infants.

The mom was surprised – and unhappy – to learn that Cronobacter could be lurking in her kitchen. More than a decade ago, investigators visited 78 households in Tennessee and cultured multiple kitchen surfaces.2C. sakazakii was recovered from 21 homes. Most of the positive cultures were from sinks, counter tops, and used dishcloths. Cronobacter has also been cultured from a variety of dried food items, including powdered milk, herbal tea, and starches.

According to the CDC, liquid formula, a product that is sterile until opened, is a safer choice for formula-fed infants who are less than 3 months of age, were born prematurely, or have a compromised immune system. When these infants must be fed powdered formula, preparing it with water heated to at least 158°F or 70°C can kill Cronobacter organisms. Parents should be instructed to boil water and let it cool for about 5 minutes before using it to mix formula.

While most cases of Cronobacter in infants have been epidemiologically linked to consumption of powdered formula, sporadic case reports describe infection in infants fed expressed breast milk. In one report, identical bacterial isolates were recovered from expressed milk fed to an infected infant and the breast pump used to express the milk.3

Moms who express milk should be instructed in proper breast pump hygiene, including washing hands thoroughly before handling breast pumps; disassembling and cleaning breast pumps kits after each use, either in hot soapy water with a dedicated brush and basin or in the dishwasher; air drying on a clean surface; and sanitizing at least daily by boiling, steaming, or using a dishwasher’s sanitize cycle.

Health care providers are encouraged to report Cronobacter cases to their state or local health departments.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Strysko J et al. Emerg Infect Dis. 2020;26(5):857-65.

2. Kilonzo-Nthenge A et al. J Food Protect 2012;75(8):1512-7.

3. Bowen A et al. MMWR Morb Mortal Wkly Rep. 2017;66:761-2.

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A 6-month-old boy presented with 2 days of looser-than-normal stools without blood or mucous. Before the onset of diarrhea, he had been fed at least two bottles of an infant formula identified in a national recall. His mom requested testing for Cronobacter sakazakii.

In mid-February, Abbott Nutrition recalled specific lots of powdered formula produced at one Michigan manufacturing facility because of possible Cronobacter contamination. To date, a public health investigation has identified four infants in three states who developed Cronobacter infection after consuming formula that was part of the recall. Two of the infants died.

Dr. Kristina A. Bryant

As media reports urged families to search their kitchens for containers of the implicated formula and return them for a refund, worried parents reached out to pediatric care providers for advice.

Cronobacter sakazakii and other Cronobacter species are Gram-negative environmental organisms that occasionally cause bacteremia and meningitis in young infants. Although these infections are not subject to mandatory reporting in most states, laboratory-based surveillance suggests that 18 cases occur annually in the United States (0.49 cases/100,00 infants).

While early reports in the literature described cases in hospitalized, preterm infants, infections also occur in the community and in children born at or near term. A Centers for Disease Control and Prevention review of domestic and international cases identified 183 children <12 months of age between 1961 and 2018 described as diagnosed with Cronobacter bacteremia or meningitis.1 Of the 79 U.S. cases, 34 occurred in term infants and 50 were community onset. Most cases occurred in the first month of life; the oldest child was 35 days of age at the onset of symptoms. Meningitis was more likely in infants born close to term and who were not hospitalized at the time of infection. The majority of infants for whom a feeding history was available had consumed powdered formula.

Back in the exam room, the 6-month-old was examined and found to be vigorous and well-appearing with normal vital signs and no signs of dehydration. The infant’s pediatrician found no clinical indication to perform a blood culture or lumbar puncture, the tests used to diagnose invasive Cronobacter infection. She explained that stool cultures are not recommended, as Cronobacter does not usually cause diarrhea in infants and finding the bacteria in the stool may represent colonization rather than infection.

The pediatrician did take the opportunity to talk to the mom about her formula preparation practices and shared a handout. Powdered formula isn’t sterile, but it is safe for most infants when prepared according to manufacturer’s directions. Contamination of formula during or after preparation can also result in Cronobacter infection in vulnerable infants.

The mom was surprised – and unhappy – to learn that Cronobacter could be lurking in her kitchen. More than a decade ago, investigators visited 78 households in Tennessee and cultured multiple kitchen surfaces.2C. sakazakii was recovered from 21 homes. Most of the positive cultures were from sinks, counter tops, and used dishcloths. Cronobacter has also been cultured from a variety of dried food items, including powdered milk, herbal tea, and starches.

According to the CDC, liquid formula, a product that is sterile until opened, is a safer choice for formula-fed infants who are less than 3 months of age, were born prematurely, or have a compromised immune system. When these infants must be fed powdered formula, preparing it with water heated to at least 158°F or 70°C can kill Cronobacter organisms. Parents should be instructed to boil water and let it cool for about 5 minutes before using it to mix formula.

While most cases of Cronobacter in infants have been epidemiologically linked to consumption of powdered formula, sporadic case reports describe infection in infants fed expressed breast milk. In one report, identical bacterial isolates were recovered from expressed milk fed to an infected infant and the breast pump used to express the milk.3

Moms who express milk should be instructed in proper breast pump hygiene, including washing hands thoroughly before handling breast pumps; disassembling and cleaning breast pumps kits after each use, either in hot soapy water with a dedicated brush and basin or in the dishwasher; air drying on a clean surface; and sanitizing at least daily by boiling, steaming, or using a dishwasher’s sanitize cycle.

Health care providers are encouraged to report Cronobacter cases to their state or local health departments.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Strysko J et al. Emerg Infect Dis. 2020;26(5):857-65.

2. Kilonzo-Nthenge A et al. J Food Protect 2012;75(8):1512-7.

3. Bowen A et al. MMWR Morb Mortal Wkly Rep. 2017;66:761-2.

A 6-month-old boy presented with 2 days of looser-than-normal stools without blood or mucous. Before the onset of diarrhea, he had been fed at least two bottles of an infant formula identified in a national recall. His mom requested testing for Cronobacter sakazakii.

In mid-February, Abbott Nutrition recalled specific lots of powdered formula produced at one Michigan manufacturing facility because of possible Cronobacter contamination. To date, a public health investigation has identified four infants in three states who developed Cronobacter infection after consuming formula that was part of the recall. Two of the infants died.

Dr. Kristina A. Bryant

As media reports urged families to search their kitchens for containers of the implicated formula and return them for a refund, worried parents reached out to pediatric care providers for advice.

Cronobacter sakazakii and other Cronobacter species are Gram-negative environmental organisms that occasionally cause bacteremia and meningitis in young infants. Although these infections are not subject to mandatory reporting in most states, laboratory-based surveillance suggests that 18 cases occur annually in the United States (0.49 cases/100,00 infants).

While early reports in the literature described cases in hospitalized, preterm infants, infections also occur in the community and in children born at or near term. A Centers for Disease Control and Prevention review of domestic and international cases identified 183 children <12 months of age between 1961 and 2018 described as diagnosed with Cronobacter bacteremia or meningitis.1 Of the 79 U.S. cases, 34 occurred in term infants and 50 were community onset. Most cases occurred in the first month of life; the oldest child was 35 days of age at the onset of symptoms. Meningitis was more likely in infants born close to term and who were not hospitalized at the time of infection. The majority of infants for whom a feeding history was available had consumed powdered formula.

Back in the exam room, the 6-month-old was examined and found to be vigorous and well-appearing with normal vital signs and no signs of dehydration. The infant’s pediatrician found no clinical indication to perform a blood culture or lumbar puncture, the tests used to diagnose invasive Cronobacter infection. She explained that stool cultures are not recommended, as Cronobacter does not usually cause diarrhea in infants and finding the bacteria in the stool may represent colonization rather than infection.

The pediatrician did take the opportunity to talk to the mom about her formula preparation practices and shared a handout. Powdered formula isn’t sterile, but it is safe for most infants when prepared according to manufacturer’s directions. Contamination of formula during or after preparation can also result in Cronobacter infection in vulnerable infants.

The mom was surprised – and unhappy – to learn that Cronobacter could be lurking in her kitchen. More than a decade ago, investigators visited 78 households in Tennessee and cultured multiple kitchen surfaces.2C. sakazakii was recovered from 21 homes. Most of the positive cultures were from sinks, counter tops, and used dishcloths. Cronobacter has also been cultured from a variety of dried food items, including powdered milk, herbal tea, and starches.

According to the CDC, liquid formula, a product that is sterile until opened, is a safer choice for formula-fed infants who are less than 3 months of age, were born prematurely, or have a compromised immune system. When these infants must be fed powdered formula, preparing it with water heated to at least 158°F or 70°C can kill Cronobacter organisms. Parents should be instructed to boil water and let it cool for about 5 minutes before using it to mix formula.

While most cases of Cronobacter in infants have been epidemiologically linked to consumption of powdered formula, sporadic case reports describe infection in infants fed expressed breast milk. In one report, identical bacterial isolates were recovered from expressed milk fed to an infected infant and the breast pump used to express the milk.3

Moms who express milk should be instructed in proper breast pump hygiene, including washing hands thoroughly before handling breast pumps; disassembling and cleaning breast pumps kits after each use, either in hot soapy water with a dedicated brush and basin or in the dishwasher; air drying on a clean surface; and sanitizing at least daily by boiling, steaming, or using a dishwasher’s sanitize cycle.

Health care providers are encouraged to report Cronobacter cases to their state or local health departments.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Strysko J et al. Emerg Infect Dis. 2020;26(5):857-65.

2. Kilonzo-Nthenge A et al. J Food Protect 2012;75(8):1512-7.

3. Bowen A et al. MMWR Morb Mortal Wkly Rep. 2017;66:761-2.

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Obesity linked to combined OSA syndrome and severe asthma

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Mon, 03/21/2022 - 11:26

Almost all patients with both obstructive sleep apnea syndrome and severe asthma fell into the obesity phenotype, not the allergy phenotype, based on data from nearly 1,500 adults.

Both asthma and sleep-disordered breathing are common conditions worldwide, and previous research suggests that obstructive sleep apnea syndrome (OSAS) and severe asthma in particular could be associated, wrote Laurent Portel, MD, of Centre Hospitalier de Libourne, France, and colleagues.

“Even if the underlying mechanisms are not well established, it is clear that both OSAS and obesity act to aggravate existing asthma, making it more difficult to control,” they said. However, the pathology of this relationship is not well-understood, and data on severe asthma phenotypes and OSAS are limited, they said.

In a study published in Respiratory Medicine and Research, the investigators reviewed data from 1,465 patients older than 18 years with severe asthma who were part of a larger, prospective multicenter study of the management of asthma patients. The larger study, developed by the Collège des Pneumologues des Hôpitaux Généraux (CPHG) is known as the FASE-CPHG (France Asthme SEvère-CPHG) and includes 104 nonacademic hospitals in France.

Diagnosis of OSAS was reported by physicians; diagnosis of severe asthma was based on the Global Initiative for Asthma criteria. The average age of the patients was 54.4 years, 63% were women, and 60% were nonsmokers.

A total of 161 patients were diagnosed with OSAS. The researchers conducted a cluster analysis on 1,424 patients, including 156 of the OSAS patients. They identified five clusters: early-onset atopic asthma (690 patients), obese asthma (153 patients), late-onset asthma (299 patients), eosinophilic asthma (143 patients), and aspirin sensitivity asthma (139 patients).

All 153 patients in the obese asthma cluster had OSAS, by contrast, none of the patients in the early atopic asthma cluster had OSAS.

Overall, obesity, male sex, high blood pressure, depression, late-onset asthma, and early-onset atopic asthma were independently associated with OSAS, with odds ratios of 5.782, 3.047, 2.875, 2.552, 1.789, and 0.622, respectively.

Notably, OSAS patients were more frequently treated with long-term oral corticosteroids than those without OSAS (30% vs. 15%, P < .0001), the researchers said. “It is possible that this treatment may be responsible for obesity, and it represents a well-known risk factor for developing OSAS,” they wrote.

Uncontrolled asthma was significantly more common in OSAS patients than in those without OSAS (77.7% vs. 69%, P = .03), and significantly more OSAS patients reported no or occasional physical activity (79.8% vs. 68.2%, P ≤ .001).

The study findings were limited by several factors including the lack of patients from primary care or university hospitals, which may limit the generalizability of the results, the reliance on physician statements for diagnosis of OSAS, and the lack of data on OSAS severity or treatment, the researchers noted.

However, the results fill a needed gap in the literature because of the limited data on severe asthma patients in real life, and identifying severe asthma patients by phenotype may help identify those at greatest risk for OSAS, they said.

“Identified patients could more easily benefit from specific examinations such as poly(somno)graphy and, consequently, could benefit from a better management of both asthma and OSAS,” they emphasized.

The larger FASE-CPHG study was supported in part by ALK, AstraZeneca, Boehringer Ingelheim, GSK, and Le Nouveau Souffle. The researchers had no financial conflicts to disclose.

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Almost all patients with both obstructive sleep apnea syndrome and severe asthma fell into the obesity phenotype, not the allergy phenotype, based on data from nearly 1,500 adults.

Both asthma and sleep-disordered breathing are common conditions worldwide, and previous research suggests that obstructive sleep apnea syndrome (OSAS) and severe asthma in particular could be associated, wrote Laurent Portel, MD, of Centre Hospitalier de Libourne, France, and colleagues.

“Even if the underlying mechanisms are not well established, it is clear that both OSAS and obesity act to aggravate existing asthma, making it more difficult to control,” they said. However, the pathology of this relationship is not well-understood, and data on severe asthma phenotypes and OSAS are limited, they said.

In a study published in Respiratory Medicine and Research, the investigators reviewed data from 1,465 patients older than 18 years with severe asthma who were part of a larger, prospective multicenter study of the management of asthma patients. The larger study, developed by the Collège des Pneumologues des Hôpitaux Généraux (CPHG) is known as the FASE-CPHG (France Asthme SEvère-CPHG) and includes 104 nonacademic hospitals in France.

Diagnosis of OSAS was reported by physicians; diagnosis of severe asthma was based on the Global Initiative for Asthma criteria. The average age of the patients was 54.4 years, 63% were women, and 60% were nonsmokers.

A total of 161 patients were diagnosed with OSAS. The researchers conducted a cluster analysis on 1,424 patients, including 156 of the OSAS patients. They identified five clusters: early-onset atopic asthma (690 patients), obese asthma (153 patients), late-onset asthma (299 patients), eosinophilic asthma (143 patients), and aspirin sensitivity asthma (139 patients).

All 153 patients in the obese asthma cluster had OSAS, by contrast, none of the patients in the early atopic asthma cluster had OSAS.

Overall, obesity, male sex, high blood pressure, depression, late-onset asthma, and early-onset atopic asthma were independently associated with OSAS, with odds ratios of 5.782, 3.047, 2.875, 2.552, 1.789, and 0.622, respectively.

Notably, OSAS patients were more frequently treated with long-term oral corticosteroids than those without OSAS (30% vs. 15%, P < .0001), the researchers said. “It is possible that this treatment may be responsible for obesity, and it represents a well-known risk factor for developing OSAS,” they wrote.

Uncontrolled asthma was significantly more common in OSAS patients than in those without OSAS (77.7% vs. 69%, P = .03), and significantly more OSAS patients reported no or occasional physical activity (79.8% vs. 68.2%, P ≤ .001).

The study findings were limited by several factors including the lack of patients from primary care or university hospitals, which may limit the generalizability of the results, the reliance on physician statements for diagnosis of OSAS, and the lack of data on OSAS severity or treatment, the researchers noted.

However, the results fill a needed gap in the literature because of the limited data on severe asthma patients in real life, and identifying severe asthma patients by phenotype may help identify those at greatest risk for OSAS, they said.

“Identified patients could more easily benefit from specific examinations such as poly(somno)graphy and, consequently, could benefit from a better management of both asthma and OSAS,” they emphasized.

The larger FASE-CPHG study was supported in part by ALK, AstraZeneca, Boehringer Ingelheim, GSK, and Le Nouveau Souffle. The researchers had no financial conflicts to disclose.

Almost all patients with both obstructive sleep apnea syndrome and severe asthma fell into the obesity phenotype, not the allergy phenotype, based on data from nearly 1,500 adults.

Both asthma and sleep-disordered breathing are common conditions worldwide, and previous research suggests that obstructive sleep apnea syndrome (OSAS) and severe asthma in particular could be associated, wrote Laurent Portel, MD, of Centre Hospitalier de Libourne, France, and colleagues.

“Even if the underlying mechanisms are not well established, it is clear that both OSAS and obesity act to aggravate existing asthma, making it more difficult to control,” they said. However, the pathology of this relationship is not well-understood, and data on severe asthma phenotypes and OSAS are limited, they said.

In a study published in Respiratory Medicine and Research, the investigators reviewed data from 1,465 patients older than 18 years with severe asthma who were part of a larger, prospective multicenter study of the management of asthma patients. The larger study, developed by the Collège des Pneumologues des Hôpitaux Généraux (CPHG) is known as the FASE-CPHG (France Asthme SEvère-CPHG) and includes 104 nonacademic hospitals in France.

Diagnosis of OSAS was reported by physicians; diagnosis of severe asthma was based on the Global Initiative for Asthma criteria. The average age of the patients was 54.4 years, 63% were women, and 60% were nonsmokers.

A total of 161 patients were diagnosed with OSAS. The researchers conducted a cluster analysis on 1,424 patients, including 156 of the OSAS patients. They identified five clusters: early-onset atopic asthma (690 patients), obese asthma (153 patients), late-onset asthma (299 patients), eosinophilic asthma (143 patients), and aspirin sensitivity asthma (139 patients).

All 153 patients in the obese asthma cluster had OSAS, by contrast, none of the patients in the early atopic asthma cluster had OSAS.

Overall, obesity, male sex, high blood pressure, depression, late-onset asthma, and early-onset atopic asthma were independently associated with OSAS, with odds ratios of 5.782, 3.047, 2.875, 2.552, 1.789, and 0.622, respectively.

Notably, OSAS patients were more frequently treated with long-term oral corticosteroids than those without OSAS (30% vs. 15%, P < .0001), the researchers said. “It is possible that this treatment may be responsible for obesity, and it represents a well-known risk factor for developing OSAS,” they wrote.

Uncontrolled asthma was significantly more common in OSAS patients than in those without OSAS (77.7% vs. 69%, P = .03), and significantly more OSAS patients reported no or occasional physical activity (79.8% vs. 68.2%, P ≤ .001).

The study findings were limited by several factors including the lack of patients from primary care or university hospitals, which may limit the generalizability of the results, the reliance on physician statements for diagnosis of OSAS, and the lack of data on OSAS severity or treatment, the researchers noted.

However, the results fill a needed gap in the literature because of the limited data on severe asthma patients in real life, and identifying severe asthma patients by phenotype may help identify those at greatest risk for OSAS, they said.

“Identified patients could more easily benefit from specific examinations such as poly(somno)graphy and, consequently, could benefit from a better management of both asthma and OSAS,” they emphasized.

The larger FASE-CPHG study was supported in part by ALK, AstraZeneca, Boehringer Ingelheim, GSK, and Le Nouveau Souffle. The researchers had no financial conflicts to disclose.

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Repurposed drug could revolutionize stem cell transplantation

Article Type
Changed
Fri, 12/16/2022 - 11:59

When the Food and Drug Administration approved abatacept in December 2021 as prophylaxis for acute graft-versus-host disease (aGVHD) in adults and children 2 years and older who are undergoing hematopoietic stem cell transplantation (HSCT), the announcement was notable for couple of key reasons.

Firstly, abatacept – initially approved in 2005 as a treatment for rheumatoid arthritis – was being repurposed for a different indication. Secondly, the new use for abatacept held promise for patients who are receiving HSCT and have trouble finding available, matched unrelated donors, a problem that disproportionately affects people of color.

Abatacept was approved based on results from the ABA2 trial, which evaluated 142 adults and children with hematologic malignancies who received a four-dose regimen of abatacept in addition to standard of care – a calcineurin inhibitor (CNI) plus methotrexate (MTX) – prior to undergoing an 8/8 HLA-matched, unrelated donor (URD) HSCT, or standard of care alone.

Another arm of the trial examined 43 recipients of a 7/8 HLA-mismatched URD HSCT who received abatacept plus standard of care, compared with a prespecified registry cohort group provided by the Center for International Blood and Marrow Transplant Research, who received CNI and MTX.

Results published in the Journal of Clinical Oncology showed the proportion of patients in the 8/8 group with severe aGVHD in the abatacept group 100 days after HSCT was not significantly lower, compared with the standard of care group (6.8% vs. 14.8%; P = .13), but there was a significant improvement in severe aGVHD–free survival (SGFS) 180 days after HSCT in the abatacept group, compared with the group that received standard of care (93.2% vs. 80%; P = .05).

Among patients in the 7/8 group, there was a significant difference in the proportion of patients with severe aGVHD favoring the abatacept group (2.3% vs. 30.2%; P < .001), and significantly improved SGFS, compared with the CIBMTR registry cohort (97.7% vs. 58.7%; P < .001)

A post hoc analysis of ABA2 published as a research letter in Blood Advances assessed abatacept using real-world data from CIBMTR. Researchers compared the 8/8 group that received standard of care with the 7/8 group that received abatacept plus standard of care and found no significant differences between relapse-free survival and overall survival for patients in the 8/8 group (adjusted hazard ratio, 0.60; 95% confidence interval, 0.28-1.28; P = .19) and 7/8 group (aHR, 0.77; 95% CI, 0.34-1.71; P = .51).

Stephen Spellman

The results suggest “abatacept may eliminate that risk of a mismatched transplant in the setting of that analysis and that small cohort that was assessed there, which is good news for patients that may not have a fully matched donor on the registry,” said Stephen Spellman, vice president at Be The Match Research (operated by the National Marrow Donor Program), and senior scientific director of CIBMTR. The findings from ABA2 “were even more impressive than necessarily expected, especially in the 7/8 arm. This is a truly substantial reduction in acute GVHD risk in that patient population,” he said in an interview.
 

 

 

Could abatacept fuel greater use of mismatched, unrelated donors?

One downside of using an HLA-mismatched donor is the potential risk of developing aGVHD, Doris M. Ponce, MD, a hematologic oncologist with Memorial Sloan Kettering Cancer Center in New York, who was not involved with the research, said in an interview.

Dr. Doris M. Ponce

Potential risk factors for aGVHD include “having a female multiparous donor, HLA-mismatched donor, unrelated donor, donor and recipient age (>40 years), [peripheral blood stem cell] stem cell graft, recipient [cytomegalovirus] serostatus (recipient/donor), myeloablative conditioning, [total body irradiation]–based conditioning, [and] gut microbiome dysbiosis,” Dr. Ponce explained.

Abatacept’s approval may have particular relevance for people of color. “It’s been understood for a long time that the likelihood of finding an 8/8 well-matched, volunteer unrelated donor varies by race or ethnicity,” Steven Devine, MD, a board-certified oncologist who is chief medical officer of Be The Match and associate scientific director at CIBMTR, said in an interview.

Mr. Spellman noted that, of the more than 35 million donors on worldwide registries accessible through the National Marrow Donor Program’s Be The Match Registry, “the match rates differ quite substantially by race and ethnicity.” Approximately 29% of African Americans find a full match on the registry, compared with 81% of Whites, 49% of Hispanics, and 47% Asian/Pacific Islanders.

“Being able to utilize a 7/8 match in a safe, effective manner using abatacept, which abatacept has been approved for, does increase those match rates quite substantially,” he explained. Among African Americans, this means the match rate increases to 84%, among Hispanics and Asian/Pacific Islanders to approximately 90%, and among Whites to about 98%.

That kind of improvement in the match rate is “the equivalent of adding more than more than 10 million ethnically diverse donors to the registry in 1 day,” Dr. Devine said. “The availability of abatacept could really level the playing field for patients in need of a lifesaving transplant.”
 

Further study of abatacept

With abatacept, “I think the results are really encouraging, and I think that further studies [are needed] to better define how the drug would work and whether it can later prevent chronic graft versus host disease,” Dr. Devine said. He said the ABA3 trial has been designed around this question, with the hypothesis that extending abatacept to an eight-dose regimen may help with chronic GVHD.

Although the FDA’s approval of abatacept was recent, Mr. Spellman said, Be The Match has seen early indications that mismatched donors in the registry are being used, which may point to an increased utilization of abatacept. “Through October to December of 2021, there was a pretty substantial increase in the use of mismatched, unrelated donors in that time frame.”

Dr. Steven Devine

Dr. Devine noted that he is seeing a lot of interest in using abatacept. “I think people are still learning how best to incorporate it into their standard of care right now.”

Meanwhile, Memorial Sloan Kettering Cancer Center is already planning to use abatacept, Dr. Ponce noted. “We have abatacept in our formulary for adult and children, and are planning on using it for patients receiving an unmodified graft from a [matched unrelated donor] or 1-allele [mismatched unrelated donor] using CNI and MTX-based GVHD prophylaxis.”

Dr. Devine and Mr. Spellman are employees of Be The Match and CIBMTR, which provided the registry control group for the ABA2 trial. Dr. Devine also reported that he has been a scientific advisory board member for Bristol-Myers Squibb. Dr. Ponce reports no relevant conflicts of interest.

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When the Food and Drug Administration approved abatacept in December 2021 as prophylaxis for acute graft-versus-host disease (aGVHD) in adults and children 2 years and older who are undergoing hematopoietic stem cell transplantation (HSCT), the announcement was notable for couple of key reasons.

Firstly, abatacept – initially approved in 2005 as a treatment for rheumatoid arthritis – was being repurposed for a different indication. Secondly, the new use for abatacept held promise for patients who are receiving HSCT and have trouble finding available, matched unrelated donors, a problem that disproportionately affects people of color.

Abatacept was approved based on results from the ABA2 trial, which evaluated 142 adults and children with hematologic malignancies who received a four-dose regimen of abatacept in addition to standard of care – a calcineurin inhibitor (CNI) plus methotrexate (MTX) – prior to undergoing an 8/8 HLA-matched, unrelated donor (URD) HSCT, or standard of care alone.

Another arm of the trial examined 43 recipients of a 7/8 HLA-mismatched URD HSCT who received abatacept plus standard of care, compared with a prespecified registry cohort group provided by the Center for International Blood and Marrow Transplant Research, who received CNI and MTX.

Results published in the Journal of Clinical Oncology showed the proportion of patients in the 8/8 group with severe aGVHD in the abatacept group 100 days after HSCT was not significantly lower, compared with the standard of care group (6.8% vs. 14.8%; P = .13), but there was a significant improvement in severe aGVHD–free survival (SGFS) 180 days after HSCT in the abatacept group, compared with the group that received standard of care (93.2% vs. 80%; P = .05).

Among patients in the 7/8 group, there was a significant difference in the proportion of patients with severe aGVHD favoring the abatacept group (2.3% vs. 30.2%; P < .001), and significantly improved SGFS, compared with the CIBMTR registry cohort (97.7% vs. 58.7%; P < .001)

A post hoc analysis of ABA2 published as a research letter in Blood Advances assessed abatacept using real-world data from CIBMTR. Researchers compared the 8/8 group that received standard of care with the 7/8 group that received abatacept plus standard of care and found no significant differences between relapse-free survival and overall survival for patients in the 8/8 group (adjusted hazard ratio, 0.60; 95% confidence interval, 0.28-1.28; P = .19) and 7/8 group (aHR, 0.77; 95% CI, 0.34-1.71; P = .51).

Stephen Spellman

The results suggest “abatacept may eliminate that risk of a mismatched transplant in the setting of that analysis and that small cohort that was assessed there, which is good news for patients that may not have a fully matched donor on the registry,” said Stephen Spellman, vice president at Be The Match Research (operated by the National Marrow Donor Program), and senior scientific director of CIBMTR. The findings from ABA2 “were even more impressive than necessarily expected, especially in the 7/8 arm. This is a truly substantial reduction in acute GVHD risk in that patient population,” he said in an interview.
 

 

 

Could abatacept fuel greater use of mismatched, unrelated donors?

One downside of using an HLA-mismatched donor is the potential risk of developing aGVHD, Doris M. Ponce, MD, a hematologic oncologist with Memorial Sloan Kettering Cancer Center in New York, who was not involved with the research, said in an interview.

Dr. Doris M. Ponce

Potential risk factors for aGVHD include “having a female multiparous donor, HLA-mismatched donor, unrelated donor, donor and recipient age (>40 years), [peripheral blood stem cell] stem cell graft, recipient [cytomegalovirus] serostatus (recipient/donor), myeloablative conditioning, [total body irradiation]–based conditioning, [and] gut microbiome dysbiosis,” Dr. Ponce explained.

Abatacept’s approval may have particular relevance for people of color. “It’s been understood for a long time that the likelihood of finding an 8/8 well-matched, volunteer unrelated donor varies by race or ethnicity,” Steven Devine, MD, a board-certified oncologist who is chief medical officer of Be The Match and associate scientific director at CIBMTR, said in an interview.

Mr. Spellman noted that, of the more than 35 million donors on worldwide registries accessible through the National Marrow Donor Program’s Be The Match Registry, “the match rates differ quite substantially by race and ethnicity.” Approximately 29% of African Americans find a full match on the registry, compared with 81% of Whites, 49% of Hispanics, and 47% Asian/Pacific Islanders.

“Being able to utilize a 7/8 match in a safe, effective manner using abatacept, which abatacept has been approved for, does increase those match rates quite substantially,” he explained. Among African Americans, this means the match rate increases to 84%, among Hispanics and Asian/Pacific Islanders to approximately 90%, and among Whites to about 98%.

That kind of improvement in the match rate is “the equivalent of adding more than more than 10 million ethnically diverse donors to the registry in 1 day,” Dr. Devine said. “The availability of abatacept could really level the playing field for patients in need of a lifesaving transplant.”
 

Further study of abatacept

With abatacept, “I think the results are really encouraging, and I think that further studies [are needed] to better define how the drug would work and whether it can later prevent chronic graft versus host disease,” Dr. Devine said. He said the ABA3 trial has been designed around this question, with the hypothesis that extending abatacept to an eight-dose regimen may help with chronic GVHD.

Although the FDA’s approval of abatacept was recent, Mr. Spellman said, Be The Match has seen early indications that mismatched donors in the registry are being used, which may point to an increased utilization of abatacept. “Through October to December of 2021, there was a pretty substantial increase in the use of mismatched, unrelated donors in that time frame.”

Dr. Steven Devine

Dr. Devine noted that he is seeing a lot of interest in using abatacept. “I think people are still learning how best to incorporate it into their standard of care right now.”

Meanwhile, Memorial Sloan Kettering Cancer Center is already planning to use abatacept, Dr. Ponce noted. “We have abatacept in our formulary for adult and children, and are planning on using it for patients receiving an unmodified graft from a [matched unrelated donor] or 1-allele [mismatched unrelated donor] using CNI and MTX-based GVHD prophylaxis.”

Dr. Devine and Mr. Spellman are employees of Be The Match and CIBMTR, which provided the registry control group for the ABA2 trial. Dr. Devine also reported that he has been a scientific advisory board member for Bristol-Myers Squibb. Dr. Ponce reports no relevant conflicts of interest.

When the Food and Drug Administration approved abatacept in December 2021 as prophylaxis for acute graft-versus-host disease (aGVHD) in adults and children 2 years and older who are undergoing hematopoietic stem cell transplantation (HSCT), the announcement was notable for couple of key reasons.

Firstly, abatacept – initially approved in 2005 as a treatment for rheumatoid arthritis – was being repurposed for a different indication. Secondly, the new use for abatacept held promise for patients who are receiving HSCT and have trouble finding available, matched unrelated donors, a problem that disproportionately affects people of color.

Abatacept was approved based on results from the ABA2 trial, which evaluated 142 adults and children with hematologic malignancies who received a four-dose regimen of abatacept in addition to standard of care – a calcineurin inhibitor (CNI) plus methotrexate (MTX) – prior to undergoing an 8/8 HLA-matched, unrelated donor (URD) HSCT, or standard of care alone.

Another arm of the trial examined 43 recipients of a 7/8 HLA-mismatched URD HSCT who received abatacept plus standard of care, compared with a prespecified registry cohort group provided by the Center for International Blood and Marrow Transplant Research, who received CNI and MTX.

Results published in the Journal of Clinical Oncology showed the proportion of patients in the 8/8 group with severe aGVHD in the abatacept group 100 days after HSCT was not significantly lower, compared with the standard of care group (6.8% vs. 14.8%; P = .13), but there was a significant improvement in severe aGVHD–free survival (SGFS) 180 days after HSCT in the abatacept group, compared with the group that received standard of care (93.2% vs. 80%; P = .05).

Among patients in the 7/8 group, there was a significant difference in the proportion of patients with severe aGVHD favoring the abatacept group (2.3% vs. 30.2%; P < .001), and significantly improved SGFS, compared with the CIBMTR registry cohort (97.7% vs. 58.7%; P < .001)

A post hoc analysis of ABA2 published as a research letter in Blood Advances assessed abatacept using real-world data from CIBMTR. Researchers compared the 8/8 group that received standard of care with the 7/8 group that received abatacept plus standard of care and found no significant differences between relapse-free survival and overall survival for patients in the 8/8 group (adjusted hazard ratio, 0.60; 95% confidence interval, 0.28-1.28; P = .19) and 7/8 group (aHR, 0.77; 95% CI, 0.34-1.71; P = .51).

Stephen Spellman

The results suggest “abatacept may eliminate that risk of a mismatched transplant in the setting of that analysis and that small cohort that was assessed there, which is good news for patients that may not have a fully matched donor on the registry,” said Stephen Spellman, vice president at Be The Match Research (operated by the National Marrow Donor Program), and senior scientific director of CIBMTR. The findings from ABA2 “were even more impressive than necessarily expected, especially in the 7/8 arm. This is a truly substantial reduction in acute GVHD risk in that patient population,” he said in an interview.
 

 

 

Could abatacept fuel greater use of mismatched, unrelated donors?

One downside of using an HLA-mismatched donor is the potential risk of developing aGVHD, Doris M. Ponce, MD, a hematologic oncologist with Memorial Sloan Kettering Cancer Center in New York, who was not involved with the research, said in an interview.

Dr. Doris M. Ponce

Potential risk factors for aGVHD include “having a female multiparous donor, HLA-mismatched donor, unrelated donor, donor and recipient age (>40 years), [peripheral blood stem cell] stem cell graft, recipient [cytomegalovirus] serostatus (recipient/donor), myeloablative conditioning, [total body irradiation]–based conditioning, [and] gut microbiome dysbiosis,” Dr. Ponce explained.

Abatacept’s approval may have particular relevance for people of color. “It’s been understood for a long time that the likelihood of finding an 8/8 well-matched, volunteer unrelated donor varies by race or ethnicity,” Steven Devine, MD, a board-certified oncologist who is chief medical officer of Be The Match and associate scientific director at CIBMTR, said in an interview.

Mr. Spellman noted that, of the more than 35 million donors on worldwide registries accessible through the National Marrow Donor Program’s Be The Match Registry, “the match rates differ quite substantially by race and ethnicity.” Approximately 29% of African Americans find a full match on the registry, compared with 81% of Whites, 49% of Hispanics, and 47% Asian/Pacific Islanders.

“Being able to utilize a 7/8 match in a safe, effective manner using abatacept, which abatacept has been approved for, does increase those match rates quite substantially,” he explained. Among African Americans, this means the match rate increases to 84%, among Hispanics and Asian/Pacific Islanders to approximately 90%, and among Whites to about 98%.

That kind of improvement in the match rate is “the equivalent of adding more than more than 10 million ethnically diverse donors to the registry in 1 day,” Dr. Devine said. “The availability of abatacept could really level the playing field for patients in need of a lifesaving transplant.”
 

Further study of abatacept

With abatacept, “I think the results are really encouraging, and I think that further studies [are needed] to better define how the drug would work and whether it can later prevent chronic graft versus host disease,” Dr. Devine said. He said the ABA3 trial has been designed around this question, with the hypothesis that extending abatacept to an eight-dose regimen may help with chronic GVHD.

Although the FDA’s approval of abatacept was recent, Mr. Spellman said, Be The Match has seen early indications that mismatched donors in the registry are being used, which may point to an increased utilization of abatacept. “Through October to December of 2021, there was a pretty substantial increase in the use of mismatched, unrelated donors in that time frame.”

Dr. Steven Devine

Dr. Devine noted that he is seeing a lot of interest in using abatacept. “I think people are still learning how best to incorporate it into their standard of care right now.”

Meanwhile, Memorial Sloan Kettering Cancer Center is already planning to use abatacept, Dr. Ponce noted. “We have abatacept in our formulary for adult and children, and are planning on using it for patients receiving an unmodified graft from a [matched unrelated donor] or 1-allele [mismatched unrelated donor] using CNI and MTX-based GVHD prophylaxis.”

Dr. Devine and Mr. Spellman are employees of Be The Match and CIBMTR, which provided the registry control group for the ABA2 trial. Dr. Devine also reported that he has been a scientific advisory board member for Bristol-Myers Squibb. Dr. Ponce reports no relevant conflicts of interest.

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Mercury and other risks of cosmetic skin lighteners

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Changed
Fri, 03/18/2022 - 09:41

Skin hyperpigmentation – whether it is caused by postinflammatory hyperpigmentation from acne or trauma to the skin, melasma, autoimmune disorders, or disorders of pigmentation – is a condition where treatment is commonly sought after in dermatology offices. Topical products used to fade hyperpigmented areas of the skin have long been used around the world, and because of safety concerns, regulations aimed at reducing potential harm or adverse effects caused by certain ingredients in these products are increasing in different countries.

For example, while extremely effective at treating most forms of hyperpigmentation, hydroquinone has been definitively linked to ochronosis, kojic acid has been linked to contact dermatitis in humans, and acid peels and retinoids are associated with irritant dermatitis, disruption of the skin barrier, and photosensitivity. In animal studies, licorice root extract has been linked to endocrine and other organ system irregularities.

ados/iStock/Getty Images

Kojic acid was banned in Japan in 2003, and subsequently in South Korea and Switzerland because of concerns over animal studies indicating that its fungal metabolite might be carcinogenic (. Hydroquinone is classified as a drug and has been banned for use in cosmetic products in Japan, the European Union, Australia, and several African nations since at least 2006 because of concerns over adrenal gland dysregulation and high levels of mercury in hydroquinone products in those countries. In Africa specifically, South Africa banned all but 2% hydroquinone in 1983, the Ivory Coast banned all skin whitening creams in 2015, and in 2016, Ghana initiated a ban on certain skin products containing hydroquinone.

The United States followed suit in February 2020 with the Food and Drug Administration introducing a ban on all OTC hydroquinone-containing products because of concerns over carcinogenicity in animal studies (which has not been shown in human studies to date). The “Coronavirus Aid, Relief, and Economic Security” (CARES) Act signed in March 2020 then made the changes effective by halting the sale of OTC hydroquinone products in the United States as of September 2020.

Mercury concerns

Despite these bans, hydroquinone continues to be sold in cosmetics and OTC products around the world and online. And despite being banned or limited in these products, mercury is still sometimes used alone or in tandem with hydroquinone as an ingredient for its desired effects in black market or unregulated skin lightening products in particular. Mercury has been used in cosmetic products as a skin lightening agent (on its own) and as a preservative.

Dr. Naissan O. Wesley

Mercury has been shown to be carcinogenic, neurotoxic, as well as cytotoxic to the renal and endocrine systems, causes reproductive toxicity, and may be bioaccumulative in wildlife and humans. There is particular concern regarding the risks of exposure in pregnant women and babies because of potential harm to the developing brain and nervous system. Initial signs and symptoms of mercury poisoning include irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, numbness and tingling in the hands, feet, or around the mouth.

Organizations such as the Zero Mercury Working Group (ZMWG) – an international coalition of public interest environmental and health nongovernmental organizations from more than 55 countries, focused on eliminating the use, release, and exposure to mercury – have been working to help ensure safety and mercury levels are below the threshold deemed allowable in hydroquinone-containing products.

 

 


On March 10, the ZMWG published the results of a new study demonstrating that skin lighteners containing mercury are still being sold online, despite bans and safety concerns. Ebay, Amazon, Shopee, Jiji, and Flipkart are among the websites still selling high mercury–containing skin lightener products. Some of them were the same offenders selling the banned products in 2019. Of the 271 online products tested from 17 countries, nearly half contained over 1 ppm of mercury, which is the legal limit that has been established by most governments and the Minamata Convention on Mercury. Based on their packaging, the majority of these products were manufactured in Asia, most often in Pakistan (43%), Thailand (8%), China (6%), and Taiwan (4%), according to the report.

Dr. Lily Talakoub

In ZMWG’s prior publications, mercury concentrations reported in some of these products ranged from 93 ppm to over 16,000 ppm. Even higher concentrations have been reported by other entities. And according to a World Health Organization November 2019 report, mercury-containing skin lightening products have been manufactured in many countries and areas, including Bangladesh, China, Dominican Republic Hong Kong SAR (China), Jamaica, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Republic of Korea, Thailand, and the United States. According to the ZMWG, 137 countries have committed to the Minamata Convention to phase out and limit mercury, including in cosmetics.

Despite bans on some of these products, consumers in the United States and other countries with bans and restrictions are still at risk of exposure to mercury-containing skin lighteners because of online sales. Hopefully, the work of the ZMWG and similar entities will continue to help limit potentially harmful exposures to mercury, while maintaining access to safe and effective methods to treat hyperpigmentation.
 

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

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Skin hyperpigmentation – whether it is caused by postinflammatory hyperpigmentation from acne or trauma to the skin, melasma, autoimmune disorders, or disorders of pigmentation – is a condition where treatment is commonly sought after in dermatology offices. Topical products used to fade hyperpigmented areas of the skin have long been used around the world, and because of safety concerns, regulations aimed at reducing potential harm or adverse effects caused by certain ingredients in these products are increasing in different countries.

For example, while extremely effective at treating most forms of hyperpigmentation, hydroquinone has been definitively linked to ochronosis, kojic acid has been linked to contact dermatitis in humans, and acid peels and retinoids are associated with irritant dermatitis, disruption of the skin barrier, and photosensitivity. In animal studies, licorice root extract has been linked to endocrine and other organ system irregularities.

ados/iStock/Getty Images

Kojic acid was banned in Japan in 2003, and subsequently in South Korea and Switzerland because of concerns over animal studies indicating that its fungal metabolite might be carcinogenic (. Hydroquinone is classified as a drug and has been banned for use in cosmetic products in Japan, the European Union, Australia, and several African nations since at least 2006 because of concerns over adrenal gland dysregulation and high levels of mercury in hydroquinone products in those countries. In Africa specifically, South Africa banned all but 2% hydroquinone in 1983, the Ivory Coast banned all skin whitening creams in 2015, and in 2016, Ghana initiated a ban on certain skin products containing hydroquinone.

The United States followed suit in February 2020 with the Food and Drug Administration introducing a ban on all OTC hydroquinone-containing products because of concerns over carcinogenicity in animal studies (which has not been shown in human studies to date). The “Coronavirus Aid, Relief, and Economic Security” (CARES) Act signed in March 2020 then made the changes effective by halting the sale of OTC hydroquinone products in the United States as of September 2020.

Mercury concerns

Despite these bans, hydroquinone continues to be sold in cosmetics and OTC products around the world and online. And despite being banned or limited in these products, mercury is still sometimes used alone or in tandem with hydroquinone as an ingredient for its desired effects in black market or unregulated skin lightening products in particular. Mercury has been used in cosmetic products as a skin lightening agent (on its own) and as a preservative.

Dr. Naissan O. Wesley

Mercury has been shown to be carcinogenic, neurotoxic, as well as cytotoxic to the renal and endocrine systems, causes reproductive toxicity, and may be bioaccumulative in wildlife and humans. There is particular concern regarding the risks of exposure in pregnant women and babies because of potential harm to the developing brain and nervous system. Initial signs and symptoms of mercury poisoning include irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, numbness and tingling in the hands, feet, or around the mouth.

Organizations such as the Zero Mercury Working Group (ZMWG) – an international coalition of public interest environmental and health nongovernmental organizations from more than 55 countries, focused on eliminating the use, release, and exposure to mercury – have been working to help ensure safety and mercury levels are below the threshold deemed allowable in hydroquinone-containing products.

 

 


On March 10, the ZMWG published the results of a new study demonstrating that skin lighteners containing mercury are still being sold online, despite bans and safety concerns. Ebay, Amazon, Shopee, Jiji, and Flipkart are among the websites still selling high mercury–containing skin lightener products. Some of them were the same offenders selling the banned products in 2019. Of the 271 online products tested from 17 countries, nearly half contained over 1 ppm of mercury, which is the legal limit that has been established by most governments and the Minamata Convention on Mercury. Based on their packaging, the majority of these products were manufactured in Asia, most often in Pakistan (43%), Thailand (8%), China (6%), and Taiwan (4%), according to the report.

Dr. Lily Talakoub

In ZMWG’s prior publications, mercury concentrations reported in some of these products ranged from 93 ppm to over 16,000 ppm. Even higher concentrations have been reported by other entities. And according to a World Health Organization November 2019 report, mercury-containing skin lightening products have been manufactured in many countries and areas, including Bangladesh, China, Dominican Republic Hong Kong SAR (China), Jamaica, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Republic of Korea, Thailand, and the United States. According to the ZMWG, 137 countries have committed to the Minamata Convention to phase out and limit mercury, including in cosmetics.

Despite bans on some of these products, consumers in the United States and other countries with bans and restrictions are still at risk of exposure to mercury-containing skin lighteners because of online sales. Hopefully, the work of the ZMWG and similar entities will continue to help limit potentially harmful exposures to mercury, while maintaining access to safe and effective methods to treat hyperpigmentation.
 

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

Skin hyperpigmentation – whether it is caused by postinflammatory hyperpigmentation from acne or trauma to the skin, melasma, autoimmune disorders, or disorders of pigmentation – is a condition where treatment is commonly sought after in dermatology offices. Topical products used to fade hyperpigmented areas of the skin have long been used around the world, and because of safety concerns, regulations aimed at reducing potential harm or adverse effects caused by certain ingredients in these products are increasing in different countries.

For example, while extremely effective at treating most forms of hyperpigmentation, hydroquinone has been definitively linked to ochronosis, kojic acid has been linked to contact dermatitis in humans, and acid peels and retinoids are associated with irritant dermatitis, disruption of the skin barrier, and photosensitivity. In animal studies, licorice root extract has been linked to endocrine and other organ system irregularities.

ados/iStock/Getty Images

Kojic acid was banned in Japan in 2003, and subsequently in South Korea and Switzerland because of concerns over animal studies indicating that its fungal metabolite might be carcinogenic (. Hydroquinone is classified as a drug and has been banned for use in cosmetic products in Japan, the European Union, Australia, and several African nations since at least 2006 because of concerns over adrenal gland dysregulation and high levels of mercury in hydroquinone products in those countries. In Africa specifically, South Africa banned all but 2% hydroquinone in 1983, the Ivory Coast banned all skin whitening creams in 2015, and in 2016, Ghana initiated a ban on certain skin products containing hydroquinone.

The United States followed suit in February 2020 with the Food and Drug Administration introducing a ban on all OTC hydroquinone-containing products because of concerns over carcinogenicity in animal studies (which has not been shown in human studies to date). The “Coronavirus Aid, Relief, and Economic Security” (CARES) Act signed in March 2020 then made the changes effective by halting the sale of OTC hydroquinone products in the United States as of September 2020.

Mercury concerns

Despite these bans, hydroquinone continues to be sold in cosmetics and OTC products around the world and online. And despite being banned or limited in these products, mercury is still sometimes used alone or in tandem with hydroquinone as an ingredient for its desired effects in black market or unregulated skin lightening products in particular. Mercury has been used in cosmetic products as a skin lightening agent (on its own) and as a preservative.

Dr. Naissan O. Wesley

Mercury has been shown to be carcinogenic, neurotoxic, as well as cytotoxic to the renal and endocrine systems, causes reproductive toxicity, and may be bioaccumulative in wildlife and humans. There is particular concern regarding the risks of exposure in pregnant women and babies because of potential harm to the developing brain and nervous system. Initial signs and symptoms of mercury poisoning include irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, numbness and tingling in the hands, feet, or around the mouth.

Organizations such as the Zero Mercury Working Group (ZMWG) – an international coalition of public interest environmental and health nongovernmental organizations from more than 55 countries, focused on eliminating the use, release, and exposure to mercury – have been working to help ensure safety and mercury levels are below the threshold deemed allowable in hydroquinone-containing products.

 

 


On March 10, the ZMWG published the results of a new study demonstrating that skin lighteners containing mercury are still being sold online, despite bans and safety concerns. Ebay, Amazon, Shopee, Jiji, and Flipkart are among the websites still selling high mercury–containing skin lightener products. Some of them were the same offenders selling the banned products in 2019. Of the 271 online products tested from 17 countries, nearly half contained over 1 ppm of mercury, which is the legal limit that has been established by most governments and the Minamata Convention on Mercury. Based on their packaging, the majority of these products were manufactured in Asia, most often in Pakistan (43%), Thailand (8%), China (6%), and Taiwan (4%), according to the report.

Dr. Lily Talakoub

In ZMWG’s prior publications, mercury concentrations reported in some of these products ranged from 93 ppm to over 16,000 ppm. Even higher concentrations have been reported by other entities. And according to a World Health Organization November 2019 report, mercury-containing skin lightening products have been manufactured in many countries and areas, including Bangladesh, China, Dominican Republic Hong Kong SAR (China), Jamaica, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Republic of Korea, Thailand, and the United States. According to the ZMWG, 137 countries have committed to the Minamata Convention to phase out and limit mercury, including in cosmetics.

Despite bans on some of these products, consumers in the United States and other countries with bans and restrictions are still at risk of exposure to mercury-containing skin lighteners because of online sales. Hopefully, the work of the ZMWG and similar entities will continue to help limit potentially harmful exposures to mercury, while maintaining access to safe and effective methods to treat hyperpigmentation.
 

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

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Cancer patients vulnerable to COVID misinformation

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Changed
Fri, 03/18/2022 - 09:40

For the past 2 years, oncology practitioners around the world have struggled with the same dilemma: how to maintain their patients’ cancer care without exposing them to COVID-19. Regardless of the country, language, or even which wave of the pandemic, the conversations have likely been very similar: weighing risks versuss benefits, and individualizing each patient’s pandemic cancer plan.

But one question most oncologists have probably overlooked in these discussions is about where their patients get their COVID information – or misinformation.

Surprisingly, this seemingly small detail could make a big difference in a patient’s prognosis.

A recent study found that adult cancer patients are more vulnerable to COVID misinformation, compared with healthy controls, building on an earlier finding of similar vulnerabilities among parents of children with cancer, compared with parents of healthy children.

“It doesn’t matter what you search for, there is an overwhelming level of information online,” the lead author on both studies, Jeanine Guidry, PhD, from Virginia Commonwealth University’s Massey Cancer Center in Richmond, said in an interview. “If misinformation is the first thing you encounter about a topic, you’re much more likely to believe it and it’s going to be very hard to convince you otherwise.”

Before the pandemic, Dr. Guidry, who is director of the Media+Health Lab at VCU, had already been studying vaccine misinformation on Pinterest and Instagram.

So when data coming out at the start of the pandemic suggested that an increase in pediatric cancer mortality might be partially because of COVID-19 misinformation, she jumped on it.

Dr. Guidry and associates designed a questionnaire involving COVID misinformation statements available online and found that parents of children with cancer were significantly more likely to endorse them, compared with parents of healthy children.

“Our advice to clinicians is you may have an issue here,” Dr. Guidry said in an interview. “You may want to check where they get their news, and if there’s any pieces of misinformation that could be harmful.”

Some beliefs, such as eating more garlic protects against COVID, are not particularly harmful, she acknowledged, but others – such as drinking bleach being protective – are quite harmful, and they often stem from the same misinformation sources.

Both of Dr. Guidry’s studies involved surveys of either adult patients with cancer or parents of children with cancer.

The adult patient survey was conducted June 1-15, 2020, and included 897 respondents, of whom 287 were patients in active treatment for cancer, 301 were survivors not currently in treatment, and 309 had no cancer history.

The parents’ survey, conducted in May 2020, included 735 parents of children aged 2-17 years, 315 of whom had children currently undergoing cancer treatment, and 420 of whom had children with no history of cancer.

Among the misinformation they were asked to agree or disagree with were statements such as “it is unsafe to receive mail from China,” “antibiotics can prevent and treat COVID-19,” and “COVID is less deadly than the ‘flu,’ ” among others.

The surveys revealed that the patients in current treatment for cancer and the parents of patients in current treatment were most likely to endorse COVID misinformation. Results from the parents’ survey showed that “believing misinformation was also more likely for fathers, younger parents, and parents with higher perceived stress from COVID-19,” the authors wrote. Among adult patients and controls, patients in active treatment were most likely to believe misinformation, with cancer survivors no longer in treatment being the least likely to believe it, compared with healthy controls who were in between.

Why the difference? The authors suggested that patients in active treatment “may seek out more information on the internet or via social media where they are more exposed to misinformation,” whereas survivors no longer undergoing treatment may be more “media savvy and have learned to be wary of questionable health information.”

In their articles, Dr. Guidry and associates advised oncologists to be aware of their patients’ potential to endorse COVID misinformation and to “proactively address this in routine visits as well as tailored written materials.” This is easier said than done, she commented, acknowledging that keeping up with the latest misinformation is a challenge.

The misinformation statements her group used in their surveys were popular early in the pandemic, but “some of them have shown fairly remarkable staying power and some have been replaced,” she said. She invited interested clinicians to contact her team for guidance on newer misinformation.

Ultimately, she believes most patients with cancer who endorse misinformation are simply afraid, and looking for help. “They’re already dealing with a level of stress from their illness and then they’re thrown into a pandemic,” Dr. Guidry said. “At some point you just want a solution. Hydroxychloroquine? Great! Horse dewormer? Fantastic! Just wanting to control the situation and not having something else to deal with.”

Both studies were funded by the National Cancer Institute at the National Institutes of Health. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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For the past 2 years, oncology practitioners around the world have struggled with the same dilemma: how to maintain their patients’ cancer care without exposing them to COVID-19. Regardless of the country, language, or even which wave of the pandemic, the conversations have likely been very similar: weighing risks versuss benefits, and individualizing each patient’s pandemic cancer plan.

But one question most oncologists have probably overlooked in these discussions is about where their patients get their COVID information – or misinformation.

Surprisingly, this seemingly small detail could make a big difference in a patient’s prognosis.

A recent study found that adult cancer patients are more vulnerable to COVID misinformation, compared with healthy controls, building on an earlier finding of similar vulnerabilities among parents of children with cancer, compared with parents of healthy children.

“It doesn’t matter what you search for, there is an overwhelming level of information online,” the lead author on both studies, Jeanine Guidry, PhD, from Virginia Commonwealth University’s Massey Cancer Center in Richmond, said in an interview. “If misinformation is the first thing you encounter about a topic, you’re much more likely to believe it and it’s going to be very hard to convince you otherwise.”

Before the pandemic, Dr. Guidry, who is director of the Media+Health Lab at VCU, had already been studying vaccine misinformation on Pinterest and Instagram.

So when data coming out at the start of the pandemic suggested that an increase in pediatric cancer mortality might be partially because of COVID-19 misinformation, she jumped on it.

Dr. Guidry and associates designed a questionnaire involving COVID misinformation statements available online and found that parents of children with cancer were significantly more likely to endorse them, compared with parents of healthy children.

“Our advice to clinicians is you may have an issue here,” Dr. Guidry said in an interview. “You may want to check where they get their news, and if there’s any pieces of misinformation that could be harmful.”

Some beliefs, such as eating more garlic protects against COVID, are not particularly harmful, she acknowledged, but others – such as drinking bleach being protective – are quite harmful, and they often stem from the same misinformation sources.

Both of Dr. Guidry’s studies involved surveys of either adult patients with cancer or parents of children with cancer.

The adult patient survey was conducted June 1-15, 2020, and included 897 respondents, of whom 287 were patients in active treatment for cancer, 301 were survivors not currently in treatment, and 309 had no cancer history.

The parents’ survey, conducted in May 2020, included 735 parents of children aged 2-17 years, 315 of whom had children currently undergoing cancer treatment, and 420 of whom had children with no history of cancer.

Among the misinformation they were asked to agree or disagree with were statements such as “it is unsafe to receive mail from China,” “antibiotics can prevent and treat COVID-19,” and “COVID is less deadly than the ‘flu,’ ” among others.

The surveys revealed that the patients in current treatment for cancer and the parents of patients in current treatment were most likely to endorse COVID misinformation. Results from the parents’ survey showed that “believing misinformation was also more likely for fathers, younger parents, and parents with higher perceived stress from COVID-19,” the authors wrote. Among adult patients and controls, patients in active treatment were most likely to believe misinformation, with cancer survivors no longer in treatment being the least likely to believe it, compared with healthy controls who were in between.

Why the difference? The authors suggested that patients in active treatment “may seek out more information on the internet or via social media where they are more exposed to misinformation,” whereas survivors no longer undergoing treatment may be more “media savvy and have learned to be wary of questionable health information.”

In their articles, Dr. Guidry and associates advised oncologists to be aware of their patients’ potential to endorse COVID misinformation and to “proactively address this in routine visits as well as tailored written materials.” This is easier said than done, she commented, acknowledging that keeping up with the latest misinformation is a challenge.

The misinformation statements her group used in their surveys were popular early in the pandemic, but “some of them have shown fairly remarkable staying power and some have been replaced,” she said. She invited interested clinicians to contact her team for guidance on newer misinformation.

Ultimately, she believes most patients with cancer who endorse misinformation are simply afraid, and looking for help. “They’re already dealing with a level of stress from their illness and then they’re thrown into a pandemic,” Dr. Guidry said. “At some point you just want a solution. Hydroxychloroquine? Great! Horse dewormer? Fantastic! Just wanting to control the situation and not having something else to deal with.”

Both studies were funded by the National Cancer Institute at the National Institutes of Health. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

For the past 2 years, oncology practitioners around the world have struggled with the same dilemma: how to maintain their patients’ cancer care without exposing them to COVID-19. Regardless of the country, language, or even which wave of the pandemic, the conversations have likely been very similar: weighing risks versuss benefits, and individualizing each patient’s pandemic cancer plan.

But one question most oncologists have probably overlooked in these discussions is about where their patients get their COVID information – or misinformation.

Surprisingly, this seemingly small detail could make a big difference in a patient’s prognosis.

A recent study found that adult cancer patients are more vulnerable to COVID misinformation, compared with healthy controls, building on an earlier finding of similar vulnerabilities among parents of children with cancer, compared with parents of healthy children.

“It doesn’t matter what you search for, there is an overwhelming level of information online,” the lead author on both studies, Jeanine Guidry, PhD, from Virginia Commonwealth University’s Massey Cancer Center in Richmond, said in an interview. “If misinformation is the first thing you encounter about a topic, you’re much more likely to believe it and it’s going to be very hard to convince you otherwise.”

Before the pandemic, Dr. Guidry, who is director of the Media+Health Lab at VCU, had already been studying vaccine misinformation on Pinterest and Instagram.

So when data coming out at the start of the pandemic suggested that an increase in pediatric cancer mortality might be partially because of COVID-19 misinformation, she jumped on it.

Dr. Guidry and associates designed a questionnaire involving COVID misinformation statements available online and found that parents of children with cancer were significantly more likely to endorse them, compared with parents of healthy children.

“Our advice to clinicians is you may have an issue here,” Dr. Guidry said in an interview. “You may want to check where they get their news, and if there’s any pieces of misinformation that could be harmful.”

Some beliefs, such as eating more garlic protects against COVID, are not particularly harmful, she acknowledged, but others – such as drinking bleach being protective – are quite harmful, and they often stem from the same misinformation sources.

Both of Dr. Guidry’s studies involved surveys of either adult patients with cancer or parents of children with cancer.

The adult patient survey was conducted June 1-15, 2020, and included 897 respondents, of whom 287 were patients in active treatment for cancer, 301 were survivors not currently in treatment, and 309 had no cancer history.

The parents’ survey, conducted in May 2020, included 735 parents of children aged 2-17 years, 315 of whom had children currently undergoing cancer treatment, and 420 of whom had children with no history of cancer.

Among the misinformation they were asked to agree or disagree with were statements such as “it is unsafe to receive mail from China,” “antibiotics can prevent and treat COVID-19,” and “COVID is less deadly than the ‘flu,’ ” among others.

The surveys revealed that the patients in current treatment for cancer and the parents of patients in current treatment were most likely to endorse COVID misinformation. Results from the parents’ survey showed that “believing misinformation was also more likely for fathers, younger parents, and parents with higher perceived stress from COVID-19,” the authors wrote. Among adult patients and controls, patients in active treatment were most likely to believe misinformation, with cancer survivors no longer in treatment being the least likely to believe it, compared with healthy controls who were in between.

Why the difference? The authors suggested that patients in active treatment “may seek out more information on the internet or via social media where they are more exposed to misinformation,” whereas survivors no longer undergoing treatment may be more “media savvy and have learned to be wary of questionable health information.”

In their articles, Dr. Guidry and associates advised oncologists to be aware of their patients’ potential to endorse COVID misinformation and to “proactively address this in routine visits as well as tailored written materials.” This is easier said than done, she commented, acknowledging that keeping up with the latest misinformation is a challenge.

The misinformation statements her group used in their surveys were popular early in the pandemic, but “some of them have shown fairly remarkable staying power and some have been replaced,” she said. She invited interested clinicians to contact her team for guidance on newer misinformation.

Ultimately, she believes most patients with cancer who endorse misinformation are simply afraid, and looking for help. “They’re already dealing with a level of stress from their illness and then they’re thrown into a pandemic,” Dr. Guidry said. “At some point you just want a solution. Hydroxychloroquine? Great! Horse dewormer? Fantastic! Just wanting to control the situation and not having something else to deal with.”

Both studies were funded by the National Cancer Institute at the National Institutes of Health. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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